-- GlaxoSmithKline to Initiate Phase IIb Clinical Trial in HIV-infected
Patients --
CAMBRIDGE, Mass., July 19 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) today announced that its collaborator,
GlaxoSmithKline (GSK), has received fast track designation for the HIV
protease inhibitor (PI) 640385 (VX-385) from the United States Food and Drug
Administration. GSK plans to initiate a Phase IIb study of 640385 in HIV-
infected patients in the third quarter of 2005. 640385 is the third, orally
active HIV protease inhibitor to be developed as part of the collaboration
agreement between Vertex and GSK.
"The Food and Drug Administration's fast track designation for 640385
highlights the productive collaboration between Vertex and GlaxoSmithKline,
which has generated three novel HIV protease inhibitor product candidates over
the past 12 years, and has established both companies as leaders in the
development of new drugs to treat HIV infection," said Joshua Boger, Ph.D.,
Chairman, President and CEO of Vertex. "This designation recognizes the
clinical and nonclinical results for 640385, which support the potential to
address the needs of patients with resistant HIV strains."
Under the FDA Modernization Act of 1997, fast track designation indicates
that the FDA will facilitate the development and may expedite the review of a
drug if it is intended for the treatment of a serious or life-threatening
condition, and demonstrates the potential to address an unmet medical need for
such a condition. Support of this fast track designation was based on
positive Phase IIa data from a clinical study of 640385 in HIV-infected
patients, as well as results from in vitro studies indicating 640385's
antiviral activity against HIV-1 strains resistant to a number of currently
marketed protease inhibitors. Vertex expects that GSK will present
preliminary Phase IIa results at a medical conference in the second half of
2005.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company
committed to the discovery and development of breakthrough small molecule
drugs for serious diseases. The Company's strategy is to commercialize its
products both independently and in collaboration with major pharmaceutical
companies. Vertex's product pipeline is principally focused on viral
diseases, inflammation, autoimmune diseases and cancer. In collaboration with
GlaxoSmithKline, Vertex currently co-promotes the protease inhibitor
Lexiva(R).
Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that (i) GSK plans to initiate a Phase IIb study of 640385 (VX-385)
in HIV-infected patients in the third quarter of 2005; (ii) the Food and Drug
Administration's fast track designation for 640385 recognizes the clinical and
nonclinical results for 640385, which support the potential to address the
needs of patients with resistant HIV strains; (iii) Vertex expects that GSK
will present preliminary Phase IIa results at a medical conference in the
second half of 2005. While management makes its best efforts to be accurate
in making forward-looking statements, such statements are subject to risks and
uncertainties that could cause Vertex's actual results to vary materially.
These risks and uncertainties include, among other things, the risks that
clinical trials for 640385 may not proceed as planned due to technical,
scientific, supply or patient enrollment issues, that actual clinical studies
of 640385 will not reflect the results obtained in earlier clinical and
nonclinical testing and other risks listed under Risk Factors in Vertex's Form
10-K filed with the Securities and Exchange Commission on March 16, 2005.
Lexiva(R) is a registered trademark of the GlaxoSmithKline group of
companies.
Vertex's press releases are available at http://www.vrtx.com.
Vertex Contacts:
Lynne H. Brum, VP, Corporate Communications and Financial Planning,
(617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Specialist, Media Relations, (617) 444-6470
SOURCE Vertex Pharmaceuticals Incorporated
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Related links:
http://www.vrtx.com
Company News On-Call:
http://www.prnewswire.com/comp/938395.html
CONTACT:
Lynne H. Brum, VP, Corporate Communications
and Financial Planning, +1-617-444-6614, or Michael Partridge,
Director, Corporate Communications, +1-617-444-6108, or Lora
Pike, Manager, Investor Relations, +1-617-444-6755, or Zachry
Barber, Specialist, Media Relations, +1-617-444-6470 all of
Vertex Pharmaceuticals Incorporated
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